Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000412831
Ethics application status
Approved
Date submitted
16/02/2021
Date registered
15/04/2021
Date last updated
4/08/2023
Date data sharing statement initially provided
15/04/2021
Date results information initially provided
4/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Proof of concept study of RECCE®327 topical antibiotic therapy for infected burn wounds
Scientific title
Proof of concept study of RECCE®327 topical antibiotic therapy for infected burn wounds in adults
Secondary ID [1] 303472 0
None
Universal Trial Number (UTN)
U1111-1264-9651
Trial acronym
RECCE®327 PoC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn wound 320783 0
Infection 320784 0
Condition category
Condition code
Injuries and Accidents 318604 318604 0 0
Burns
Infection 318605 318605 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Polyacrolein polyethylene glycol oligomer mixture (0.045 gram/gram) will be administered topically as a spray solution to saturate the wound over a 14 day treatment period.

The first ten participants will be allocated to daily application; in practical terms this will mean at least five applications within the first seven days of treatment. The next twenty participants will be allocated to three times a week application. Dressing changes will be aligned with antibiotic application.

During each outpatient clinic visit, the burn wound site will be assessed clinically and study assessments completed. Thereafter, as needed, irrigation and debridement of the wound will be performed in accordance with the standard Burns Unit procedures avoiding chlorhexidine and other cleansing agents with residual effect.

Antibiotic will be administered by a dressing clinic nurse. The antibiotic will be sprayed onto the whole of the infected burn ulcer until the wound is visibly wet/saturated throughout. The wound will be then left open until visibly dried or for at least five minutes before applying a dressing. This will be to ensure adequate absorption of the topical antibiotic into the burn wound bed, to prevent immediate uptake into dressings and maximise the clinical efficacy of this antimicrobial preparation. The wound will then be covered using a standard foam dressing.

Adherence to the intervention will be monitored with records of the number of dressings attended, the number of antibiotic administrations and the number of pumps delivered.

All the procedures, including opening the wound, irrigation, debridement, the preparation and application of the topical antibiotic, and re-dressing, should take approximately 15 min to complete.
Intervention code [1] 319761 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326565 0
Infection status of wound determined by unblinded clinical investigator using the consensus clinical criteria of the International Wound Infection Institute
Timepoint [1] 326565 0
day 14 post-commencement of intervention
Secondary outcome [1] 391897 0
Incident adverse signs or symptoms observed by unblinded clinical investigator
Timepoint [1] 391897 0
day 28 post-commencement of intervention

Eligibility
Key inclusion criteria
(a) patients equal to or over 18 years of age;
(b) patients with clinical signs and symptoms of local wound infection;
(c) patients without any other investigational specialised wound care material other than the topical RECCE®327 applications;
(d) patients anticipated to have a minimum follow-up period of 1 month.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Unable to provide informed consent
(b) Deep structures (bone or tendon) on view
(c) Signs or symptoms of spreading or systemic infection (IWII criteria)
(d) Pregnant or breastfeeding
(e) Known allergy to any components of the RECCE®327 solution or any of its excipients, including: polyethylene glycol (PEG) 200, the active oligomer (4.76%; [7.80% TM001]), acrolein monomer (0.189ppm), and conjugated carbonyls (1.15 ABS @ 230 nm, & 0.75 ANS @ 272nm).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis will be descriptive providing details of the clinical characteristics and microbiology of the infected wounds as well as the outcomes (clinical or toxicity) at the end of therapy, and also 2 weeks thereafter. Analysis of the primary outcome will be conducted using all participants that have received at least one dose of the study drug. Pre-defined sub-group analysis will separate (1) daily and three times a week dosing intervals; (2) early and late burn wound infections with late being greater than 6 weeks from date of injury. We consider a desirable outcome of this novel therapy to be at least 70% complete response, which would be a clinically significant improvement to the previously reported 50% response rate.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/06/2021
Actual
20/09/2021
Date of last participant enrolment
Anticipated
1/12/2022
Actual
27/04/2022
Date of last data collection
Anticipated
31/12/2022
Actual
18/05/2022
Sample size
Target
30
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 18732 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 33176 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 307889 0
Charities/Societies/Foundations
Name [1] 307889 0
Fiona Wood Foundation
Country [1] 307889 0
Australia
Funding source category [2] 307890 0
Commercial sector/Industry
Name [2] 307890 0
Recce Pharmaceuticals Ltd
Country [2] 307890 0
Australia
Primary sponsor type
Government body
Name
South Metropolitan Health Service
Address
14 Barry Marshall Parade, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 308600 0
None
Name [1] 308600 0
Address [1] 308600 0
Country [1] 308600 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307888 0
South Metropolitan Health Service HREC
Ethics committee address [1] 307888 0
South Metropolitan Health Service Executive
Level 2, Education Building, Fiona Stanley Hospital
14 Barry Marshall Parade
MURDOCH Western Australia 6150
Ethics committee country [1] 307888 0
Australia
Date submitted for ethics approval [1] 307888 0
Approval date [1] 307888 0
14/10/2020
Ethics approval number [1] 307888 0

Summary
Brief summary
Burn wound infections continue to cause significant health problems for patients following a range of burn injuries. Current therapeutic options are sub-optimal and are often associated with delayed wound healing. We therefore plan to study the antibiotic, RECCE®327 to assess the clinical effectiveness and safety of this agent for the treatment on infected chronic burn ulcers. The study is exploratory and will deliver the new RECCE®327 antimicrobial via an innovative spray-on formulation, specially developed for this study. We plan to study two dosing schedules with ten participants receiving daily and a further twenty receiving three times a week application of the spray-on RECCE®327 antibiotic, over a 14 day study period. If this exploratory study suggests clinical effectiveness and no toxicity signal, we then plan to undertake a much larger study of the novel RECCE®327 antibiotic comparing it to standard care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108830 0
Dr Edward Raby
Address 108830 0
Fiona Stanley Hospital
11 Robin Warren Dr, Murdoch WA 6150
Country 108830 0
Australia
Phone 108830 0
+61 8 6152 0319
Fax 108830 0
Email 108830 0
edward.raby@health.wa.gov.au
Contact person for public queries
Name 108831 0
Dr Edward Raby
Address 108831 0
Fiona Stanley Hospital
11 Robin Warren Dr, Murdoch WA 6150
Country 108831 0
Australia
Phone 108831 0
+61 8 6152 0319
Fax 108831 0
Email 108831 0
edward.raby@health.wa.gov.au
Contact person for scientific queries
Name 108832 0
Dr Edward Raby
Address 108832 0
Fiona Stanley Hospital
11 Robin Warren Dr, Murdoch WA 6150
Country 108832 0
Australia
Phone 108832 0
+61 8 6152 0319
Fax 108832 0
Email 108832 0
edward.raby@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The study protocol, participant information sheet and consent form as well as all de-identified individual participant data collected in the electronic case report form will be made available.
When will data be available (start and end dates)?
These documents and data will be available beginning 3 months and ending 5 years after publication of the primary study analysis in a peer reviewed medical journal.
Available to whom?
They will be available to researchers who provide a methodologically sound proposal that has been reviewed by a health research ethics committee or recognised equivalent.
Available for what types of analyses?
The scope of secondary analysis will be limited to the approved proposal.
How or where can data be obtained?
Initial request should be made to the principal investigator: Edward.Raby@health.wa.gov.au

A data transfer agreement between the requestor and South Metropolitan Health Service will be required.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Plain language summaryNo Six participants were enrolled and commenced trial... [More Details]

Documents added automatically
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